A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Corindus Inc.
- Enrollment
- 952
- Locations
- 20
- Primary Endpoint
- Clinical Success
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
Detailed Description
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Candidates will be included in the study only if all of the following conditions are met:
- •Age ≥18 years;
- •Patients with coronary artery disease with clinical indication for PCI;
- •Patient deemed appropriate for robotic-assisted PCI; and
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
- •Candidates will be excluded from the study if any of the following conditions are present:
- •Failure/inability/unwillingness to provide informed consent; or
- •The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
Outcomes
Primary Outcomes
Clinical Success
Time Frame: Discharge or 72 hours post intervention, whichever comes first.
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
Technical Success
Time Frame: Procedure
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
Secondary Outcomes
- Overall Procedure Time(Procedure)
- Fluoroscopy Time(Procedure)
- Patient Radiation Exposure(Procedure)
- PCI Procedure Time(Procedure)